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LC determination of entacapone in tablets: in vitro dissolution studies.
J Chromatogr Sci. 2010 Oct; 48(9):755-9.JC

Abstract

The aim of the study was to develop and validate a dissolution procedure for entacapone-coated tablets. Several conditions such as medium composition, pH, surfactant concentration, and rotation speed were evaluated. The best dissolution conditions were achieved using apparatus 2, 900 mL of medium containing acetate buffer pH 5.3 at a rotation speed of 50 rpm, and a reversed-phase liquid chromatographic method for the quantification of the drug from the dissolution test, as well as to evaluate the dissolution profiles for tablets. The procedure was validated by specificity, linearity, accuracy, repeatability, intermediate precision, and robustness. The chromatographic method employed an Agilent Eclipse XDB RP-18 (150 × 4.6 mm i.d., particle size 5 μm) with a mobile phase consisting of water pH 3.0 and acetonitrile (65:35, v/v) at a flow rate of 2.0 mL/min. The dissolution procedure developed and validated was adequate for its purpose and could be applied for quality control for entacapone-coated tablets because there is no official monograph.

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Authors+Show Affiliations

Paim CS
Programa de Pós-Graduação em Ciências Farmacêuticas, Faculdade de Farmácia, Universidade Federal do Rio Grande do Sul, Porto Alegre-RS, Brazil. csoldatelli30@hotmail.com
Martins MT
No affiliation info available
Malesuik MD
No affiliation info available
Steppe M
No affiliation info available

MeSH

Antiparkinson AgentsCatecholsChromatography, Reverse-PhaseHydrogen-Ion ConcentrationLinear ModelsNitrilesReproducibility of ResultsSensitivity and SpecificitySolubilityTablets, Enteric-Coated

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20875238

Citation

Paim, Clésio S., et al. "LC Determination of Entacapone in Tablets: in Vitro Dissolution Studies." Journal of Chromatographic Science, vol. 48, no. 9, 2010, pp. 755-9.
Paim CS, Martins MT, Malesuik MD, et al. LC determination of entacapone in tablets: in vitro dissolution studies. J Chromatogr Sci. 2010;48(9):755-9.
Paim, C. S., Martins, M. T., Malesuik, M. D., & Steppe, M. (2010). LC determination of entacapone in tablets: in vitro dissolution studies. Journal of Chromatographic Science, 48(9), 755-9.
Paim CS, et al. LC Determination of Entacapone in Tablets: in Vitro Dissolution Studies. J Chromatogr Sci. 2010;48(9):755-9. PubMed PMID: 20875238.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - LC determination of entacapone in tablets: in vitro dissolution studies. AU - Paim,Clésio S, AU - Martins,Magda T, AU - Malesuik,Marcelo D, AU - Steppe,Martin, PY - 2010/9/30/entrez PY - 2010/9/30/pubmed PY - 2011/1/12/medline SP - 755 EP - 9 JF - Journal of chromatographic science JO - J Chromatogr Sci VL - 48 IS - 9 N2 - The aim of the study was to develop and validate a dissolution procedure for entacapone-coated tablets. Several conditions such as medium composition, pH, surfactant concentration, and rotation speed were evaluated. The best dissolution conditions were achieved using apparatus 2, 900 mL of medium containing acetate buffer pH 5.3 at a rotation speed of 50 rpm, and a reversed-phase liquid chromatographic method for the quantification of the drug from the dissolution test, as well as to evaluate the dissolution profiles for tablets. The procedure was validated by specificity, linearity, accuracy, repeatability, intermediate precision, and robustness. The chromatographic method employed an Agilent Eclipse XDB RP-18 (150 × 4.6 mm i.d., particle size 5 μm) with a mobile phase consisting of water pH 3.0 and acetonitrile (65:35, v/v) at a flow rate of 2.0 mL/min. The dissolution procedure developed and validated was adequate for its purpose and could be applied for quality control for entacapone-coated tablets because there is no official monograph. SN - 1945-239X UR - https://www.unboundmedicine.com/medline/citation/20875238/LC_determination_of_entacapone_in_tablets:_in_vitro_dissolution_studies_ L2 - https://academic.oup.com/chromsci/article-lookup/doi/10.1093/chromsci/48.9.755 DB - PRIME DP - Unbound Medicine ER -